Device Classification Name |
Console, Heart-Lung Machine, Cardiopulmonary Bypass
|
510(k) Number |
K080832 |
Device Name |
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER |
Applicant |
SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 03/25/2008 |
Decision Date | 07/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|